EUROLAB laboratory provides testing and compliance services within the scope of ISO 7886-3 standard. Developed by the International Organization for Standardization (ISO), this part of the ISO 7886 standard specifies the characteristics and performance of sterile disposable hypodermic syringes featuring an auto-disable syringe, intended for fixed dose delivery of the vaccine immediately after filling.
Syringes can be made of plastic, rubber or other materials and can be with or without needle and needle protection. This document does not specify the design of the auto-disable syringe feature.
This document does not apply to syringes for use with insulin (under ISO 8537), syringes for use with power-driven syringe pumps (under ISO 7886-2), anti-reuse syringes (under ISO 7886-4) or designed syringes. will be pre-filled (under the ISO 11040 series). Does not address compatibility with injection fluids/vaccine.
The preparation of this document was considered a high priority to prevent reuse of fixed dose immunization syringes. The reuse of injection equipment without sterilization has led to an increasing transmission of blood-borne pathogens.
The World Health Organization (WHO) has produced a specification for syringes (often referred to as "auto-disable" syringes) that become ineffective after one use. It was agreed that an additional part of the ISO 7886 series would be needed to cover "auto-disable" syringes, and ISO 7886-1 and ISO 7886-2 would be left unchanged as there would be a large number of devices in common use. It is not intended to comply with recommended auto-disable features.
Limiting syringe types to only include the type with an auto-disable feature that is automatically activated and remains active from the moment the injection is initiated has been discussed. Evaluation of potential hazards based only on hypothetical use indicates that the strain with an auto-disable feature that is automatically activated and remains active from the moment the injection is initiated is potentially safer than the other strains.
However, as there is currently no reliable risk data from field use, no consensus has been reached on the eradication or preservation of the species. Therefore, it was decided to keep all species and limit this revision to compliance with ISO 7886-1:2017 and initiate a new revision if new field studies or incident reports indicate a need for a revision.
It is recognized that syringes designed to reduce the risk of needle stick injury may also comply with this document. In some countries, national regulations may take precedence over the requirements in this document.
Among the services provided by our organization within the framework of material testing services, there are also ISO 7886-3 standard tests. Do not hesitate to contact our laboratory EUROLAB for your testing and certification requests.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
